NCT04093388

Brief Summary

The purpose of the study is to find out if a self-administered (by the patient) Papanicolaou (Pap) smear is as accurate as a traditional Pap smear administered by a healthcare provider.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
14mo left

Started Apr 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress81%
Apr 2021Jun 2027

First Submitted

Initial submission to the registry

September 16, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 18, 2019

Completed
1.6 years until next milestone

Study Start

First participant enrolled

April 26, 2021

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Last Updated

March 31, 2026

Status Verified

March 1, 2026

Enrollment Period

5.7 years

First QC Date

September 16, 2019

Last Update Submit

March 25, 2026

Conditions

Cervical Cancer

Keywords

Pap smearPapanicolaouself-collectioncervical cancer screening

Outcome Measures

Primary Outcomes (1)

  • Evaluate the self-PAP against the traditional Pap smear procedure

    Baseline through 14 days

Study Arms (2)

Self-PAP

EXPERIMENTAL

Each patient will participate in both arms of the study on the day of the clinical examination. This arm includes the self-administered Papanicolaou (Pap) smear. They will be compared to each other for congruence and accuracy.

Diagnostic Test: Self-PAP

Traditional Pap

EXPERIMENTAL

Each patient will participate in both arms of the study on the day of the clinical examination. This arm includes the traditional, healthcare provider obtained Papanicolaou (Pap) smear specimen. They will be compared to each other for congruence and accuracy.

Diagnostic Test: Traditional Pap smear

Interventions

Traditional Pap smearDIAGNOSTIC_TEST

A single cohort of 250 patients will be recruited from among those who need a Papanicolaou (Pap) smear for routine cervical cancer screening, to perform a self-administered Pap smear immediately prior to the traditional Pap smear. Blinded assessment of both tests will be then conducted.

Traditional Pap
Self-PAPDIAGNOSTIC_TEST

A single cohort of 250 patients will be recruited from among those who need a Papanicolaou (Pap) smear for routine cervical cancer screening, to perform a self-administered Pap smear immediately prior to the traditional Pap smear. Blinded assessment of both tests will be then conducted.

Self-PAP

Eligibility Criteria

Age21 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female of at least 21 years of age and not over 65 presenting who need routine cervical cancer screening per national guidelines.

You may not qualify if:

  • prior history of cervical cancer or a positive Pap smear, have had a total hysterectomy (removal of uterus and cervix), or currently enrolled in any other cancer prevention study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Cahaba Medical Care - West End

Birmingham, Alabama, 35211, United States

RECRUITING

Cahaba Medical Care - Ensley

Birmingham, Alabama, 35218, United States

RECRUITING

Cahaba Medical Care

Centreville, Alabama, 35042, United States

RECRUITING

Related Publications (9)

  • Chen K, Ouyang Y, Hillemanns P, Jentschke M. Excellent analytical and clinical performance of a dry self-sampling device for human papillomavirus detection in an urban Chinese referral population. J Obstet Gynaecol Res. 2016 Dec;42(12):1839-1845. doi: 10.1111/jog.13132. Epub 2016 Sep 20.

    PMID: 27647799BACKGROUND

  • De Alba I, Anton-Culver H, Hubbell FA, Ziogas A, Hess JR, Bracho A, Arias C, Manetta A. Self-sampling for human papillomavirus in a community setting: feasibility in Hispanic women. Cancer Epidemiol Biomarkers Prev. 2008 Aug;17(8):2163-8. doi: 10.1158/1055-9965.EPI-07-2935.

    PMID: 18708409BACKGROUND

  • Chang CC, Tseng CJ, Liu WW, Jain S, Horng SG, Soong YK, Hsueh S, Pao CC. Clinical evaluation of a new model of self-obtained method for the assessment of genital human papilloma virus infection in an underserved population. Chang Gung Med J. 2002 Oct;25(10):664-71.

    PMID: 12518778BACKGROUND

  • Haguenoer K, Sengchanh S, Gaudy-Graffin C, Boyard J, Fontenay R, Marret H, Goudeau A, Pigneaux de Laroche N, Rusch E, Giraudeau B. Vaginal self-sampling is a cost-effective way to increase participation in a cervical cancer screening programme: a randomised trial. Br J Cancer. 2014 Nov 25;111(11):2187-96. doi: 10.1038/bjc.2014.510. Epub 2014 Sep 23.

    PMID: 25247320BACKGROUND

  • Jahic M, Jahic E. Diagnostic Approach to Patients with Atypical Squamous Cells of Undetermined Significance Cytologic Findings on Cervix. Med Arch. 2016 Jul 27;70(4):296-298. doi: 10.5455/medarh.2016.70.296-298.

    PMID: 27703293BACKGROUND

  • Kobetz E, Seay J, Amofah A, Pierre L, Bispo JB, Trevil D, Gonzalez M, Poitevien M, Koru-Sengul T, Carrasquillo O. Mailed HPV self-sampling for cervical cancer screening among underserved minority women: study protocol for a randomized controlled trial. Trials. 2017 Jan 13;18(1):19. doi: 10.1186/s13063-016-1721-6.

    PMID: 28086983BACKGROUND

  • Wright TC Jr, Denny L, Kuhn L, Pollack A, Lorincz A. HPV DNA testing of self-collected vaginal samples compared with cytologic screening to detect cervical cancer. JAMA. 2000 Jan 5;283(1):81-6. doi: 10.1001/jama.283.1.81.

    PMID: 10632284BACKGROUND

  • Labani S, Asthana S. Human papillomavirus viral load on careHPV testing of self-collected vaginal samples vs. clinician-collected cervical samples. Eur J Obstet Gynecol Reprod Biol. 2014 Oct;181:233-9. doi: 10.1016/j.ejogrb.2014.08.005. Epub 2014 Aug 13.

    PMID: 25171269BACKGROUND

  • Ogilvie GS, van Niekerk D, Krajden M, Smith LW, Cook D, Gondara L, Ceballos K, Quinlan D, Lee M, Martin RE, Gentile L, Peacock S, Stuart GCE, Franco EL, Coldman AJ. Effect of Screening With Primary Cervical HPV Testing vs Cytology Testing on High-grade Cervical Intraepithelial Neoplasia at 48 Months: The HPV FOCAL Randomized Clinical Trial. JAMA. 2018 Jul 3;320(1):43-52. doi: 10.1001/jama.2018.7464.

    PMID: 29971397BACKGROUND

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • John B Waits, MD

    PI

    PRINCIPAL INVESTIGATOR

Central Study Contacts

John B Waits, MD

CONTACT

2052772379john.waits@cahabamedicalcare.com

Lacy Smith, PhD

CONTACT

2053378726lacy.smith@cahabamedicalcare.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Pathologist (outcomes assessor) will be blinded
Purpose
SCREENING
Intervention Model
PARALLEL
Model Details: A single cohort of 250 patients will be recruited from among those who need a Papanicolaou (Pap) smear for routine cervical cancer screening, to perform a self-administered Pap smear immediately prior to the traditional Pap smear. Blinded assessment of both tests will be then conducted.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 16, 2019

First Posted

September 18, 2019

Study Start

April 26, 2021

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

June 30, 2027

Last Updated

March 31, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(3)